Regulatory Affairs Specialist – International Markets

Vem İlaç San. ve Tic. A.Ş.

Vem İlaç is a Turkish pharmaceutical company headquartered in Istanbul.

With more than 1,700 colleagues, we carry out all our manufacturing at our EU-approved, cGMP-certified facility in Çerkezköy, enabling access to our medicines in more than 50 countries.

Our second facility in Lüleburgaz, scheduled to begin operations soon, will be the largest pharmaceutical production site in Türkiye and the region. This investment significantly expands our capacity and strengthens our global competitiveness.

Guided by science, we remain committed to meeting both today’s health needs and tomorrow’s challenges, as we continue to work for a healthier future.

Regulatory Affairs Specialist - International Markets

About The Role

We are looking for a Regulatory Affairs Specialist to support our growing international operations and manage regulatory activities for assigned markets throughout the product lifecycle.

The role will be responsible for the preparation, submission and lifecycle management of marketing authorization dossiers, coordination of country-specific regulatory requirements, and effective communication with international partners and internal stakeholders, ensuring compliance with applicable local and international regulations

Job Description

• Preparing, compiling and submitting marketing authorization dossiers in CTD format in line with country-specific regulatory requirements.
  
  
• Managing marketing authorization, variation, renewal and deficiency response processes for assigned international markets.
  
  
• Coordinating SmPC, PIL, labeling and artwork preparation/revision in accordance with relevant authority requirements.
  
  
• Following up country-specific documentation needs, including official certificates, notarization, legalization and apostille processes.
  
  
• Coordinating required regulatory documentation and responses with Quality, R&D, Production and other relevant departments.
  
  
• Maintaining communication with international partners and monitoring submission timelines and authority requests.
  
  
• Monitoring relevant regulatory updates and maintaining accurate regulatory records, correspondence and archives.
  
  
• Monitoring changes in national and international pharmaceutical regulations, guidelines and authority requirements, and assessing their potential impact on ongoing and planned regulatory activities.
  
  
• Ensuring effective cross-functional coordination with Quality Assurance, Quality Control, R&D, Production, Supply Chain, Commercial and other relevant departments throughout regulatory processes.

Qualifications

• Bachelor's degree in Pharmacy, Biology, Molecular Biology & Genetics, Chemistry or Chemical Engineering. 
  
  
• Minimum 3 years of experience in Regulatory Affairs or a related functions within the pharmaceutical industry, preferably with exposure to international markets.
  
  
• Proven experience in the preparation and lifecycle management of CTD dossiers.
  
  
• Familiarity with international regulatory documentation requirements, legalization/apostille processes and pharmaceutical artwork management is preferred.
  
  
• Advanced level of written and spoken English, with the ability to communicate effectively with international partners.
  
  
• Proficiency in MS Office applications. 
  
  
• Strong planning, organization and follow-up skills with the ability to manage multiple countries, products and deadlines simultaneously.
  
  
• Proactive, solution-oriented and comfortable working in a dynamic international environment.
  
  
• Willingness and ability to travel domestically and internationally when required.
  
  
• Based in Ankara.